MAUDE Adverse Event Report: HAEMONETICS CORPORATION MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM; MCS+ (RBC),LIST NO 08150-110-E

Model Number 08150-110-E

Device Problems Fluid/Blood Leak (1250); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in the incident.A field service engineer was dispatched and inspected the mcs+ machine.It was noticed that there was a fluid spill on an electrical component.The engineer replace the component parts and ran the functional tests.The unit meets manufacturers specifications and is ready for use.

Event Description

On (b)(6) 2019, haemonetics was informed by the customer of a malfunction regarding smoke coming from machine when it was turned on.

• Brand Name: MCS®+ 8150 MULTICOMPONENT COLLECTION SYSTEM
• Type of Device: MCS+ (RBC),LIST NO 08150-110-E
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9987693
• MDR Text Key: 188559786
• Report Number: 1219343-2020-00035
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08150-110-E
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1